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WO2006047590A2 - Compositions et traitements de vaginose bacterienne - Google Patents

Compositions et traitements de vaginose bacterienne Download PDF

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Publication number
WO2006047590A2
WO2006047590A2 PCT/US2005/038554 US2005038554W WO2006047590A2 WO 2006047590 A2 WO2006047590 A2 WO 2006047590A2 US 2005038554 W US2005038554 W US 2005038554W WO 2006047590 A2 WO2006047590 A2 WO 2006047590A2
Authority
WO
WIPO (PCT)
Prior art keywords
composition
plant polyphenol
bacterial vaginosis
epicatechin
epigallocatechin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2005/038554
Other languages
English (en)
Other versions
WO2006047590A3 (fr
Inventor
Paul Wegener
Yukihiko Hara
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mitsui Norin Co Ltd
Epitome Pharmaceuticals Ltd USA
Original Assignee
Mitsui Norin Co Ltd
Epitome Pharmaceuticals Ltd USA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mitsui Norin Co Ltd, Epitome Pharmaceuticals Ltd USA filed Critical Mitsui Norin Co Ltd
Publication of WO2006047590A2 publication Critical patent/WO2006047590A2/fr
Publication of WO2006047590A3 publication Critical patent/WO2006047590A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/82—Theaceae (Tea family), e.g. camellia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants

Definitions

  • Bacterial vaginosis is a genito-urinary tract infection that is typically caused by anaerobic bacteria, including Gardnerella vaginalis, Mobiluncus sp., Bacteroides sp. and Mycoplasma homini, and various compositions and methods for treatment of BV are known in the art.
  • metronidazole l-(2-Hydroxy-l-ethyl)-2-methyl-5-nitroimidazole
  • Ferris D. G, Litaker, M.S, Woodward, L.
  • Mathis D., Hendrich, J. in J. Fam. Pract.
  • the present invention is directed to compositions and methods of treatment of bacterial vaginosis in which a composition comprising a plant polyphenol or plant polyphenol mixture is used as an active ingredient.
  • a method of providing health care to a patient suffering from bacterial vaginosis comprises a step of providing a composition that includes a plant polyphenol, and another step of providing an instruction to administer the plant polyphenol containing composition in an amount effective to treat the bacterial vaginosis.
  • the plant polyphenol is prepared from a green tea extract (e.g., polyphenon E), comprises a flavan-3-ol compound (synthetic or isolated from a plant), and/or is selected from the group consisting of (-)-epigallocatechin gallate, (-)-epicatechin gallate, (-)-epigallocatechin, and (-)-epicatechin.
  • Contemplated compositions are preferably topically applied, and especially suitable compositions are formulated as a suppository, a cream, a foam, and/or a liquid. Where desirable, the composition may also be included in a tampon. Alternatively, or additionally, contemplated compositions may also be formulated as orally administered compositions. Plant polyphenol amounts effective to treat the bacterial vaginosis are typically at least 50 mg/administration, more typically at least 250 mg/administration, and most typically at least 500 mg/administration.
  • a composition for treatment of bacterial vaginosis comprises a plant polyphenol in a formulation for topical administration, wherein the plant polyphenol is present at a concentration effective to treat bacterial vaginosis. Therefore, in a further aspect of the inventive subject matter, a method of marketing a product for woman's health comprises a step of providing contemplated compositions and/or an information that a plant polyphenol (and most preferably polyphenon E and/or at least one of (-)-epigallocatechin gallate, (-)-epicatechin gallate, (-)- epigallocatechin, and (-)-e ⁇ icatechin) is effective in treatment of bacterial vaginosis.
  • a plant polyphenol and most preferably polyphenon E and/or at least one of (-)-epigallocatechin gallate, (-)-epicatechin gallate, (-)- epigallocatechin, and (-)-e ⁇ icatechin) is effective in treatment of bacterial vaginosis.
  • bacterial vaginosis can be treated by topic and/or systemic administration of a plant polyphenol or mixture of various plant polyphenols.
  • the plant polyphenols are isolated from green tea ⁇ Camellia sinensis) or grape seeds, and even more preferably comprise a mixture of plant polyphenols (e.g., Polyphenon E, commercially available from Mitsui Norm).
  • plant polyphenol refers to any naturally occurring or synthetic polyphenol that is commonly found in a plant. Therefore, particularly preferred plant polyphenols include flavan-3-ol compounds (e.g., (-)-epigallocatechin gallate (EGCG), (-)-epicatechin gallate (ECG), (-)-epigallocatechin (EGC), or (-)-epicatechin (EC)).
  • EGCG epigallocatechin gallate
  • ECG epigallocatechin gallate
  • ECG epigallocatechin gallate
  • ECC epigallocatechin
  • EC epigallocatechin
  • treat and treatment also include administrations that result in improvement in clinical parameters, and/or improvement in subjective well-being. Still further, the terms “treat” and “treatment” also refer to prophylactic administration of contemplated compounds or compositions to reduce likelihood of development or worsening of bacterial vaginosis.
  • a topical composition for vaginal administration comprises a mixture of green tea polyphenols (e.g., Polyphenon E) at a concentration of between about 10 wt% to about 20 wt%.
  • green tea polyphenols e.g., Polyphenon E
  • Such compositions are typically formulated as a suppository with a melting point of between about 90 0 F to about 100 0 F and are most preferably packaged in a single dose under exclusion of oxygen. Suppositories are most preferably administered twice daily over at least fourteen consecutive days, or until the bacterial vaginosis is resolved.
  • compositions will include those enriched in natural polyphenols from green tea (e.g., green tea extract), or combinations of two or more of EGCG, ECG, EGC, and EC.
  • Preferred plant polyphenols especially include tea catechin polyphenols represented by Formula (T) below in which R 1 is H or OH, and R 2 is H or a 3,4,5-trihydroxy benzoyl group;
  • green tea catechins include: (-)epicatechin in which R 1 and R 2 are H; (-)epigallocatechm, in which R 1 is OH and R 2 is H; (-)epicatechin gallate, in which R 1 is H and R 2 is 3,4,5-trihydroxy benzoyl; and (-)epigallocatechin gallate, in which R 1 is OH and R 2 is 3,4,5-trihydroxy benzoyl.
  • contemplated tea catechins include theaflavin, theaflavin monogallate A, theaflavin monogallate B, and theaflavin digallate.
  • contemplated topical compositions will include the plant polyphenol in an amount that provides at least 50 mg, more preferably at least 250 mg, and most preferably at least 500 mg of the plant polyphenol per administration.
  • Suitable topical vehicles other than suppositories include those that can be applied as a cream, gel, or foam. Alternatively, it is contemplated that suitable formulations may be prepared as a liquid for application via a douche. There are numerous such topical formulations known in the art, and it is contemplated that all of such known formulations are suitable for use herein.
  • the green tea extract is administered via a tampon, wherein the tampon comprises therapeutically effective amounts of the green tea extract.
  • a tampon may include contemplated plant polyphenols in a dried or otherwise at least partially dehydrated form. Alternatively, the polyphenols may also be incorporated into the tampon in a topical formulation as presented above. Consequently, it should be recognized that treatments according to the inventive subject matter can be continued throughout the menstrual cycle where needed.
  • compositions for treatment of bacterial vaginosis include those that comprise a plant polyphenol in a formulation for topical administration, wherein the plant polyphenol is present at a concentration effective to treat bacterial vaginosis.
  • Such compositions may further include one or more antibiotics known for treatment of bacterial vaginosis, and particularly contemplated antibiotics include metronidazole, beta-lactam antibiotics, chloramphenicol, rifampin, tobramycin, vancomycin, and/or virginiamycin.
  • contemplated plant polyphenols may also be administered via oral route for treatment of bacterial vaginosis.
  • the oral administration comprises administration of Polyphenon E in a capsule.
  • the plant polyphenol may be administered as a single polyphenol (e.g., EGCG) or mixture of several isolated polyphenols, or as crude plant extract, m less preferred aspects, the plant polyphenols may also be orally administered as a tea.
  • contemplated treatment kits will include a composition comprising a plant polyphenol (e.g., a green tea extract in oral and/or topical formulation), and an optional instruction to use the kit components at a schedule effective to treat bacterial vaginosis.
  • Typical treatment schedules include those in which topical application is between once several times daily to weekly (e.g., twice daily, once daily, every other day, once weekly), or even less frequently, wherein topical and oral administration may be parallel, alternating, or at sequential.
  • a composition that includes a plant polyphenol, and in which an instruction is provided to administer the composition in an amount effective to treat the bacterial vaginosis.
  • administration may be topical, oral, and most preferably a combination of topical and oral.
  • the inventors also contemplate a method of marketing a product for women's health in which contemplated compositions are provided and/or in which information is provided that a plant polyphenol (most preferably comprising at least one of (-)-epigallo- catechin gallate, (-)-epicatechin gallate, (-)-epigallocatechin, and (-)-epicatechin) is effective in treatment of bacterial vaginosis.
  • a plant polyphenol most preferably comprising at least one of (-)-epigallo- catechin gallate, (-)-epicatechin gallate, (-)-epigallocatechin, and (-)-epicatechin
  • Especially contemplated forms of information include printed information associated with the product (e.g., packaging insert or package containing contemplated compositions), or information provided to the user/public, which may be printed (e.g., advertisement), displayed (e.g., TV commercial), or in audible (e.g., radio commercial) and/or electronic form (e.g., as information provided via the Internet).
  • printed information associated with the product e.g., packaging insert or package containing contemplated compositions
  • information provided to the user/public which may be printed (e.g., advertisement), displayed (e.g., TV commercial), or in audible (e.g., radio commercial) and/or electronic form (e.g., as information provided via the Internet).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Engineering & Computer Science (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

L'invention concerne une vaginose bactérienne traitée au moyen de méthodes et de compositions comprenant un ou plusieurs polyphénol(s) végétal/taux comme ingrédients actifs. Les voies préférées d'administration des polyphénols végétaux précités sont les voies topique et orale, et les polyphénols végétaux particulièrement préférés sont préparés à partir du thé vert (par exemple, Polyphenon E) et/ou peuvent comprendre l'épigallocatéchine gallate, l'épicatéchine gallate, l'épigallocatéchine et l'épicatéchine.
PCT/US2005/038554 2004-10-26 2005-10-26 Compositions et traitements de vaginose bacterienne Ceased WO2006047590A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/974,253 US20050090564A1 (en) 2003-10-28 2004-10-26 Compositions and treatments of bacterial vaginosis
US10/974,253 2004-10-26

Publications (2)

Publication Number Publication Date
WO2006047590A2 true WO2006047590A2 (fr) 2006-05-04
WO2006047590A3 WO2006047590A3 (fr) 2006-07-06

Family

ID=36228419

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/038554 Ceased WO2006047590A2 (fr) 2004-10-26 2005-10-26 Compositions et traitements de vaginose bacterienne

Country Status (2)

Country Link
US (1) US20050090564A1 (fr)
WO (1) WO2006047590A2 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006104564A1 (fr) * 2005-03-28 2006-10-05 Kimberly-Clark Worldwide, Inc. Procede de prevention et/ou de traitement d'infections vaginales et vulvaires
US7619008B2 (en) 2004-11-12 2009-11-17 Kimberly-Clark Worldwide, Inc. Xylitol for treatment of vaginal infections
EP2179722A1 (fr) * 2008-10-24 2010-04-28 Heinrich-Pette-Institut für experimentelle Virologie und Immunologie Formation topique pour la prévention de la transmission sexuelle d'une infection virale
US7786176B2 (en) 2005-07-29 2010-08-31 Kimberly-Clark Worldwide, Inc. Vaginal treatment composition containing xylitol

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150118267A1 (en) * 2013-10-30 2015-04-30 Dongning Li Method of using theaflavin

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5700636A (en) * 1990-10-19 1997-12-23 Becton Dickinson And Company Methods for selectively detecting microorganisms associated with vaginal infections in complex biological samples
US5811471A (en) * 1997-09-15 1998-09-22 Shanbrom Technologies Llc Disinfectant plastic sponge material
KR100319973B1 (ko) * 1998-12-05 2002-04-22 이인수 녹차카테킨을 유효성분으로 하는 자궁경부 상피내종양 예방 또는 치료제 조성물
WO2000071138A2 (fr) * 1999-05-25 2000-11-30 Gregor Reid Administration orale de lactobacillus pour la conservation d'un bon etat de sante chez la femme
US6462030B1 (en) * 1999-07-19 2002-10-08 New York Blood Center, Inc. Method for inactivating bacteria associated with bacterial vaginosis using cellulose acetate phthalate and/or hydroxypropyl methycellulose phthalate
US6468989B1 (en) * 2000-07-13 2002-10-22 Dow Pharmaceutical Sciences Gel compositions containing metronidazole
KR100449898B1 (ko) * 2001-02-26 2004-09-22 휴먼사이언스테크놀러지(주) 질위생구
US20030211173A1 (en) * 2002-05-08 2003-11-13 Veach Tom C. Lubrication composition

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7619008B2 (en) 2004-11-12 2009-11-17 Kimberly-Clark Worldwide, Inc. Xylitol for treatment of vaginal infections
WO2006104564A1 (fr) * 2005-03-28 2006-10-05 Kimberly-Clark Worldwide, Inc. Procede de prevention et/ou de traitement d'infections vaginales et vulvaires
US7786176B2 (en) 2005-07-29 2010-08-31 Kimberly-Clark Worldwide, Inc. Vaginal treatment composition containing xylitol
EP2179722A1 (fr) * 2008-10-24 2010-04-28 Heinrich-Pette-Institut für experimentelle Virologie und Immunologie Formation topique pour la prévention de la transmission sexuelle d'une infection virale

Also Published As

Publication number Publication date
US20050090564A1 (en) 2005-04-28
WO2006047590A3 (fr) 2006-07-06

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